jRCT2011240073招募中不适用
A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Amgen K.K.
- 入组人数
- 675
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- Male
入选标准
- •Participant has provided informed consent prior to initiation of any study-specific activities/procedures.
- •Age >= 18 years (or >= legal age within the country if it is older than 18 years) at the time of signing the informed consent.
- •Participant must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
- •mCRPC with >= 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained within 28 days prior to enrollment.
- •Evidence of progressive disease, defined as 1 or more PCWG3 criteria:
- •Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL.
- •Soft-tissue progression defined as an increase >= 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions.
- •Progression of bone disease: evaluable disease or new bone lesion(s) by bone scan (2+2 PCWG3 criteria, Scher et al, 2016).
- •Participants must have had a prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (< 50ng/dL or < 1.7 nmol/L).
- •Prior treatment with at least one ARDT.
- •Prior treatment with one taxane therapy. Prior treatment with docetaxel in the hormone-sensitive setting is permitted. Participants who received two or more prior chemotherapy regimens in the castrate-resistant setting are not eligible.
- •Prior treatment with radioligand therapy (RLT), radionuclide therapy (Radium-223), poly ADP-ribose polymerase (PARP) inhibitor, or immune checkpoint inhibitor is permitted.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or
- •Adequate organ function.
排除标准
- •Prior & Concomitant Therapy:
- •Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
- •Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks prior to the first dose of study treatment, not including androgen suppression therapy.
- •Prior Prostate-Specific Membrane Antigen (PSMA) radioligand therapy (RLT) within 2 months of the first dose of study treatment unless participants received < 2 cycles of therapy. Participants who received 1 cycle of PSMA RLT within 35 days prior to the first dose of study treatment are also excluded.
- •Participants who started a bisphosphonate or denosumab regimen within 4 weeks prior to the first dose of study treatment.
- •Radiation therapy within 4 weeks prior to the first dose of study treatment (or local or focal radiotherapy within 2 weeks prior to the first dose of study treatment).
- •Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological therapy, or investigational therapy.
- •Disease Related:
- •Participants with a history of central nervous system (CNS) metastasis.
- •Unresolved toxicities from prior anti-tumor therapy with CTCAE version 5.0 events grade above 1 or baseline, with the exception of alopecia or toxicities that are stable and well controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor.
结局指标
主要结局
-
1. Overall Survival (OS) [Time Frame: Up to approximately 43 months]
次要结局
- Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Central Review (BICR)(Up to approximately 43 months)
- Objective Response Rate per RECIST v1.1 as Assessed by BICR(Up to approximately 43 months)
- Duration of Response (DOR) per RECIST v1.1 as Assessed by BICR(Up to approximately 43 months)
- Time to Response (TTR) per RECIST v1.1 as Assessed by BICR(Up to approximately 43 months)
研究者
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